Expert in LIMS Implementation - Spain
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- To assess QC requirements for the implementation of LIMS at 3P QC regarding current needs and analytical services provided to internal and external clients (URS).
- To assess the LIMS application system for the different requirements and performances within QC.
- To review and verify existing workflows and flowcharts of current activities to be translated into the system.
- To generate workflows and custom fields for the existing analytical methods.
- To generate a workflow system for the submission of samples and corresponding analysis requests.
- To established attributes and roles for the different users of the system.
- To verify correct implementation of workflows within the existing system.
- To correct any deviation observed during the implementation.
- To drive the qualification of the system and perform activities for all verifications which could be required.
- To generate SOPs for the different activities within the use of the system and its management.
- To train QC staff in the implementation and use of the system.
- 3 years of experience in the Pharmaceutical or preferably Biotechnological Industry in the field of Quality Control, under GMP environment.
- Practical experience in implementing LIMS.
- Knowledge in Pharmacy/Chemistry/Biochemistry and/or equivalent.
- Knowledge and experience in software applications and implementation.
- Valuable working experience in GMP or GLP environments.